← Back to Search

Platelet Transfusion

Extended Cold Stored Platelets for Blood Loss in Cardiac Surgery (CHASE Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Moritz Stolla, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is scheduled for redo, triple valve, or complex aortic cardiac surgery with cardiopulmonary bypass

Subject age is greater than or equal to 18 years of age

Must not have

Subject refuses blood products

Subject has active infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-op through day 28.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well platelets stored at cold conditions work in cardiac surgery patients who are actively bleeding and need a platelet transfusion.

Who is the study for?

Adults over 18, who can speak/read English and weigh more than 40 kg, scheduled for complex cardiac surgery with bypass. They must understand/sign the consent form, not be in other studies, and use contraception if applicable. Excluded are those with severe transfusion reactions, certain medical conditions or treatments post-surgery, thrombocytopenia, pregnancy/breastfeeding status, prisoners, active infections or history of unprovoked blood clots.

What is being tested?

The trial is testing the safety and effectiveness of cold-stored platelets (1-6°C) kept for 10-14 days versus room temperature stored platelets kept up to 7 days in patients undergoing cardiac surgery who need a platelet transfusion due to active bleeding.

What are the potential side effects?

Potential side effects may include reactions related to the transfusion process such as fever or allergic responses. There's also a risk of bleeding complications or clotting issues due to the condition of the stored platelets.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a complex heart surgery involving multiple valves or the aorta with cardiopulmonary bypass.

Select...

I am 18 years old or older.

Select...

I weigh more than 40 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I refuse to receive blood transfusions.

Select...

I currently have an active infection.

Select...

I have had a blood clot in my leg or lung without an obvious cause.

Select...

I have a known bleeding disorder.

Select...

I am scheduled to receive a blood transfusion from my own blood or a directed donor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-op through day 28.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-op through day 28.

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-op through day 28. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of the recruitment and accrual into the study protocol.

Secondary study objectives

Chest tube output volume

Hemostatic agents administered

Hospital free days

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cold stored platelets in 100% plasma stored for 10-14 daysExperimental Treatment1 Intervention

Cold stored apheresis platelets in 100% plasma stored for 10-14 days, maximum of up to three units (3x10\^11/unit) from the start of surgery until 24 hours after the end of surgery

Group II: Room temperature stored platelets in 100% plasma stored for up to 7 daysActive Control1 Intervention

Room temperature stored platelets in 100% plasma stored for up to 7 days, maximum of up to three units (3x10\^11/unit) from the start of surgery until 24 hours after the end of surgery

0 / 8Eligibility criteria met